Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
(Reuters)—A synthetic version of a medicine traditionally extracted from chili plant relieved knee pain among osteoarthritis patients for up to six months, data showed, bringing Centrexion Therapeutics a step closer to developing a safe and effective analgesic. The drug, designed to be injected at the site of pain, is being developed by the privately-held company…
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
(Reuters Health)—State programs that require physicians to check drug registries before writing prescriptions appeared to slash the odds of doctor-shopping for opioid pain relievers, a new study found. “Our study shows that prescription-drug monitoring programs are a promising component of a multifaceted strategy to address the opioid epidemic,” Ryan Mutter, one of the study authors,…
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
(Reuters Health)—Scientists are testing an experimental drug that’s designed to have the painkilling power of morphine without some of the side effects that can lead to overdose deaths. Initial results in mice with the compound known for now as PZM21 suggest it might be less addictive than morphine and other opiate painkillers and avoid respiratory…
FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…
CHICAGO—Despite the complicated politics surrounding medical marijuana, cannabis has a wide variety of medical benefits and potential benefits, but the risks need to be understood, said Daniel Clauw, MD, director of the Chronic Pain and Fatigue Research Center at the University of Michigan, in a session at the ACR’s 2016 State-of-the-Art Clinical Symposium. Effects It’s…
(Reuters Health)—State programs that monitor narcotic prescriptions help prevent 10 opioid-overdose deaths a day in the U.S., yet improvements could save another two people a day, a new study finds. States with the most robust programs—ones that tracked a greater number of potentially addictive medications and updated their databases at least weekly—saw the biggest drops…
WASHINGTON (Reuters)—The U.S. Senate on Monday moved closer to confirming Dr. Robert Califf to lead the U.S. Food and Drug Administration, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move designed to prevent the opponents from blocking the confirmation indefinitely, the Senate voted 80 to…